Mantell Associates are currently partnered with a unique biotech organisation who operate within a niche space, and currently building out a new manufacturing facility following significant investment.
As a Bioprocess Engineer, you will be responsible for designing, optimizing, and troubleshooting bioprocesses for the production of biological products. Your expertise will contribute to the development of efficient and scalable manufacturing processes that meet quality standards and regulatory requirements. This is a dynamic role that requires a strong background in bioprocessing, technical proficiency, and a passion for innovation.
Bioprocess Engineer - Responsibilities:
Bioprocess Design and Development:
Design, develop, and optimize bioprocesses for the production of biological products, including upstream and downstream operations.
Conduct process simulations, modeling, and scale-up studies to ensure efficient and cost-effective production.
Collaborate with cross-functional teams, such as Research and Development, Manufacturing, and Quality Assurance, to ensure seamless process integration
Process Optimization and Troubleshooting:
Continuously evaluate and optimize bioprocesses to enhance yield, productivity, and product quality.
Identify process bottlenecks, perform root cause analysis, and implement corrective actions to improve process performance.
Troubleshoot process-related issues and provide timely solutions to ensure smooth manufacturing operations.
Technology Transfer and Scale-Up:
Support technology transfer activities, including the transfer of processes from R&D to manufacturing.
Collaborate with internal and external stakeholders to ensure successful scale-up and implementation of new processes.
Provide technical expertise during process validation activities, including process characterization, qualification, and validation protocols.
Documentation and Compliance:
Generate and maintain detailed process documentation, including batch records, standard operating procedures (SOPs), and process descriptions.
Ensure compliance with cGMP regulations, safety guidelines, and relevant quality management systems.
Collaborate with the Quality Assurance team to conduct risk assessments, support investigations, and implement corrective actions.
Continuous Improvement and Innovation:
Stay up-to-date with industry trends, new technologies, and scientific advancements in bioprocessing.
Identify opportunities for process improvement, automation, and innovation to enhance efficiency, productivity, and product quality.
Initiate and lead process optimization projects to drive operational excellence and ensure competitiveness in the market.
Bioprocess Engineer - Requirements:
Bachelor's or Master's degree in Chemical Engineering, Biotechnology, or a related field. A Ph.D. is a plus.
Proven experience in bioprocess engineering, process development, or related roles within the biopharmaceutical industry.
Strong knowledge of bioprocessing principles, including upstream and downstream unit operations, process scale-up, and technology transfer.
Proficiency in process simulation and modeling software, such as Aspen Plus, SuperPro Designer, or similar tools.
Familiarity with cGMP regulations and quality management systems in the biopharmaceutical industry.
Experience with statistical analysis and design of experiments (DoE) for process optimization.
Excellent problem-solving skills and the ability to apply scientific principles to troubleshoot process-related issues.
Strong organizational skills, attention to detail, and the ability to manage multiple projects simultaneously.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.